Senior Director, Global Regulatory Lead

Role Summary

Senior Director, Global Regulatory Lead based in Washington State. As the key decision-maker responsible for the development and execution of global regulatory strategies for Immunome’s therapeutic portfolio, you will maximize regulatory success across complex programs and collaborate across teams to ensure compliance with corporate objectives throughout development and lifecycle. Reports to the Vice President, Regulatory Affairs.

Responsibilities

• Define and implement global regulatory strategies that adapt to changing regulatory and business needs.
• Communicate key developments to project teams and stakeholders, ensuring alignment and sound judgment.
• Anticipate risks and devise solutions, understanding the likelihood of technical success for proposed strategies.
• Lead the Global Regulatory Team, fostering a high-performance culture through coaching and mentoring; collaborate with regional regulatory leads and vendors to ensure compliance with local regulations for global submissions.
• Communicate effectively with internal and external partners, advocating for regulatory positions in governance and cross-functional committees.
• Identify regulatory risks and opportunities, developing strategies to mitigate risks and enhance success rates.
• Ensure timely preparation and submission of regulatory submissions (e.g., INDs, BLAs, NDAs) while maintaining compliance with regional and global requirements; act as the primary contact with global health authorities and lead FDA meetings.
• Monitor industry trends and regulatory changes, adapting strategies to mitigate impacts on product development.

Qualifications

• Bachelor’s degree in a relevant scientific discipline. (Required)
• A minimum of 10 years experience in global regulatory affairs in the pharmaceutical/biotechnology industry. (Required)
• Proven success in leading regulatory submissions and obtaining approvals in major markets. (Required)
• Experience developing oncology therapeutics is strongly preferred. (Preferred)

Skills

• Direct experience leading regulatory submissions, health authority meetings and interactions with in-depth knowledge of the FDA, EMA and other global health authorities
• Comprehensive and disciplined approach to regulatory risk management and compliance through deep expertise and understanding of the oncology therapeutic area
• Highly collaborative self-starter and team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
• Outstanding communication, analytical, organizational and time management skills
• Experience and passion to work with small teams, ability to work comfortably under pressure under evolving scenarios and tight deadlines
• Detail-minded yet flexible work style; manage multiple projects and timelines simultaneously, and rapidly change priorities based on business needs

Education

• Bachelor’s degree in a relevant scientific discipline. (Required)